Association of Periodontitis and Preeclampsia During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855504
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : April 13, 2015
University Grants Commission, New Delhi
Information provided by (Responsible Party):
Ashok Kumar, Maulana Azad Medical College

Brief Summary:
Infections affecting the mother during pregnancy may produce alterations in the normal cytokine and hormone-regulated gestation, which could result in preeclampsia, preterm labor, premature rupture of membranes, and preterm birth. Therefore, pregnant women with periodontal disease may show an alteration in the cytokine levels which may cause preeclampsia in them.

Condition or disease
Preeclampsia Periodontal Disease

Detailed Description:
The enrolled subjects will be evaluated on the basis of a pre-designed and pre-tested proforma with respect to history and clinical examination, obstetrics examination and ultrasonography. The periodontal examination consists of assessments at vestibular, lingual, mesial and distal sites of all present teeth.Five ml venous blood sample will be drawn from the patient at the time of enrollment before 20 weeks of gestation for the levels of cytokines (IL-4, IL-10, IFN-g and TNF-α. All the subjects will be followed- up till delivery. At the time of delivery, the details of pregnancy outcome (maternal and fetal) along with the measurement of the blood pressure will be recorded. A repeat of oral health evaluation will be done within 48 hours of delivery.

Study Type : Observational
Actual Enrollment : 528 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy
Study Start Date : February 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease

All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation

Primary Outcome Measures :
  1. Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primigravidae women with 14-20 weeks of gestation.

Inclusion Criteria:

  • Singleton live pregnancy.
  • Sure of her dates. (known dates of the last menstrual period)
  • Age group 18-35 years.

Exclusion Criteria:

  • Chronic hypertension
  • Polyhydramnios
  • Congenital malformation in fetus
  • Diabetes
  • Renal disease
  • Cardiovascular disease
  • Urolithiasis
  • Parathyroid disease
  • Systolic blood pressure measurement of more than 140mm Hg and diastolic blood pressure more than 90 mm Hg at first visit.
  • Infections (bacterial vaginosis and chorioamnionitis)
  • Antibiotic use during pregnancy
  • Excessive body mass index
  • Less than 20 natural teeth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855504

Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Maulana Azad Medical College
University Grants Commission, New Delhi
Principal Investigator: Ashok Kumar, MD Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India

Responsible Party: Ashok Kumar, Director Professor, Maulana Azad Medical College Identifier: NCT00855504     History of Changes
Other Study ID Numbers: 34-499/2008(SR)
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Ashok Kumar, Maulana Azad Medical College:

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications